Background: Isavuconazole, administered as isavuconazonium sulfate (ISAVUSULF), is a broad-spectrum triazole agent for the treatment of invasive fungal disease. In phase 3 studies, ISAVUSULF showed comparable efficacy to voriconazole and amphotericin B for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM), respectively. Objectives: The objective of this study is to determine all-cause mortality and safety outcomes among adults with IM and/or IA non-fumigatus (nf) treated with ISAVUSULF or other antifungal therapies (AFT). Patients and methods: This multicentre, non-interventional registry enrolled patients aged ≥18 years with IM or IA-nf who received systemic AFT from January 2016 to November 2018. Patients received primary ISAVUSULF, non-primary ISAVUSULF, or other AFT, as monotherapy or combination therapy. The primary end point was all-cause mortality at Days 42 and 84; safety outcomes were adverse drug reactions (ADRs) to ISAVUSULF. Results: Of 204 patients enrolled, 74 received primary ISAVUSULF, 30 non-primary ISAVUSULF, and 100 other AFT. All-cause mortality through Day 42 was numerically lower in the non-primary ISAVUSULF group than in the primary ISAVUSULF and other AFT groups, for patients with IM (20.0% vs. 33.3% and 41.3%, respectively) or IA-nf (0% vs. 14.8% and 17.8%, respectively). All-cause mortality tended to be lower with combination therapy than with monotherapy, except for patients with IM receiving primary ISAVUSULF. Of 111 patients receiving ISAVUSULF, 14 (12.6%) reported ADRs, of whom three (2.7%) developed serious ADRs. There were no drug-related deaths. Conclusions: This study supports the effectiveness and tolerability of ISAVUSULF in clinical practice. Further research is required to confirm the value of ISAVUSULF combination therapy over monotherapy.
|Number of pages||13|
|State||Published - Feb 2022|
Bibliographical noteFunding Information:
G. R. T. has received research grants and consultancy fees from Astellas, Amplyx, Cidara, and Mayne and was on the Data Review Committee (DRC) for Pfizer. M. H. M. has received investigator‐initiated research grants and consultancy fees from Astellas and Scynexis. M. H. N. has received research grants from the National Institutes of Health, grants for investigator‐initiated research from Astellas, Scynexis, Mayne, Pulmocide, T2Biosystems, and Cidara, and consulting fees from Scynexis, Mayne, and Pulmocide. L. O‐Z. has received grants from Astellas, Cidara, Scynexis, and Amplyx and personal fees from Astellas, Pfizer, Therapeutics Inc, Viracor, Octapharma, Mayne, F2G, Gilead, and Cidara. J‐A. H. Y. has received research support for the University of Minnesota from Cidara and Scynexis and grants from Astellas and Mayne. C. F. has received research support from Karius. N. M. C. has received a research grant from Astellas Pharma. A. S. has received a grant from Astellas Pharma Global Development, Inc, and personal fees from Scynexis. L. K. and R. C‐D. are employees of Astellas Pharma Global Development, Inc. D. P. K. has received research support from Astellas and honoraria from Merck, Astellas, Gilead, Cidaras, Pulmocide, and Mayne Pharmaceuticals. D. P. K. is a member of the Data Review Committee of Cidaras, Inc, and AbbVie, Inc. He acknowledges the Robert C Hickey Chair endowment. J. G‐D. and R. N. G. have none to declare.
This work was initiated and supported by Astellas Pharma Global Development, Inc Medical writing support was provided by Michael Lappin, PhD, Sarah Whitfield, PhD, and Iona Easthope, DPhil, for Cello Health MedErgy, funded by Astellas Pharma Inc The authors acknowledge support from a number of colleagues who assisted with the study, including Beth Plummer, Debbie Plummer, Dana Hargis, and Malissia VanHook from the University of Kentucky ID Clinical Research team and Karen Vigil, MD from the University of Texas in Houston. These data were accepted as an oral presentation to the 30th European Congress of Clinical Microbiology & Infectious Disease (ECCMID), Paris, France, 18–21 April 2020.
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ASJC Scopus subject areas
- Infectious Diseases